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EMA on the use of Real-World Data/Evidence in ...

04/30/2025

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In March, 2025, the European Medicines Agency (EMA) released a “Reflection paper on use of real-world data (RWD) in non-interventional studies (NIS) to generate real-world evidence (RWE) for regulatory purposes” as a guidance for stakeholders on quality planning, conduct and analysis of NISs that intend to use RWD to generate RWE.

EMA on the use of Real-World Data/Evidence in Non-Interventional Studies
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FDA Warning Letter to Sponsor – Records, ...

04/22/2025

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In November 2024, the US Food and Drug Administration (FDA) issued a warning letter to the sponsor as a result of a BioResearch Monitoring Program (BIMO) inspection which observed objectionable conditions. The warning letter cited two violations of the Title 21 CFR.

FDA Warning Letter to Sponsor – Records, Reports, and Audit Trails
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OGPS and FDA discuss FDA’s Role in the DoH ...

04/08/2025

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In December 2024, following the release of the 2024 revision of the Declaration of Helsinki (DoH), US Food and Drug Administration (FDA) staff shared the FDA’s perspective on what their role was in the development of the 2024 DoH and how it may impact FDA procedures. The DoH is intended to guide clinical research involving human participants that is often used as the foundation for other guidelines such as the International Council for Harmonisation (ICH) Good Clinical Practice (GCP).

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WMA Adopts 2024 Revision of the Declaration of ...

03/24/2025

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In October 2024, the World Medical Association (WMA) announced the adoption of the 2024 revision of the Declaration of Helsinki (DoH) during the 75th WMA General Assembly in Helsinki, Finland, the same location where the Declaration was initially adopted 60 years prior.

WMA Adopts 2024 Revision of the Declaration of Helsinki
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IRB Warning Letter from BIMO Inspection

03/10/2025

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On September 27, 2024, the US Food and Drug Administration (FDA) issued a warning letter to an Institutional Review Board (IRB) as a result of a (BIMO) inspection from July of 2023. BIMO inspections evaluate compliance with of FDA regulatory requirements, in this case, title 21 CFR Parts 50, protection of human subject, and 56, Intuitional Review Boards.

IRB Warning Letter from BIMO Inspection

New FDA Guidance! Enhancing the Diversity of Clinical Trial Populations

11/23/2020

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The Food and Drug Administration (FDA) released a final guidance in November 2020, “Enhancing the Diversity of Clinical Trial Populations - Eligibility Criteria, Enrollment Practices, and Trial Designs.” Certain populations are underrepresented in clinical trials, even though they are part of the target audience for the investigational product once approved. The guidance outlines methods the sponsor can use to support more diverse enrollment that more accurately reflects the target population, in accordance with requirements in the FDA Reauthorization Act of 2017 (FDARA).

FDA Digital Health Center of Excellence & SaMDs

11/17/2020

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On September 22, 2020, the US Food & Drug Administration (FDA) issued a release announcing the launch of the Digital Health Center of Excellence. The Digital Health Center of Excellence, a division of the Center for Devices and Radiological Health (CDRH), is designed to promote the advancement of digital health technologies by “providing technological advice, coordinating and supporting work being done across the FDA, advancing best practices, and reimagining digital health device oversight.”

How Do You Monitor Sticky Notes at the Site While Remote Monitoring? – Part 1

11/03/2020

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Many sites now use eReg vendors such as Veeva, Florence, RealTime, etc. as a source document depository database for monitors to review and leave source questions within. This allows the monitors to conduct SDV on certified source remotely.

Question 1: But what about life before COVID and visits that occurred before? How do monitors verify that source questions (i.e., sticky notes on the binder left at a previous monitoring onsite visit) are addressed? How do you go about confirming the source is finished being monitored?

Comment Now! FDA Draft Guidance on PRO Instruments

10/27/2020

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The Food and Drug Administration (FDA) recently released a draft guidance entitled “Principles for Selecting, Developing, Modifying and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Clinical Evaluation.” This draft guidance follows a guidance from 2019, “Patient-Reported Outcome Measures: Use in Medical Product Development to support Labeling Claims”, and a push starting in 2016 by the Center for Devices and Radiological Health (CDRH) to incorporate the use of patient-reported outcomes (PROs) in evaluating medical devices.